FDA 510(k)

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup

K-Number: K261984 · 2026-07-17

Decision Date2026-07-17

Product CodeNFT

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech., LLC. It received FDA 510(k) clearance on 2026-07-17 under 510(k) number K261984. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup?

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2026-07-17. The listed applicant is Assure Tech., LLC. The 510(k) number is K261984.

When did AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup receive FDA 510(k) clearance?

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup received FDA 510(k) clearance on 2026-07-17, under 510(k) number K261984.

Who is the listed applicant for AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup?

The FDA 510(k) record lists Assure Tech., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup?

The FDA product code for AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup is NFT.

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Other records listing Assure Tech., LLC as applicant

K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

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Related Devices (Code: NFT)

K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLC K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupVivachek Biotech (Hangzhou) Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.